The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2006 by Poznan University of Medical Sciences. Recruitment status was: Recruiting

Sponsor:

Poznan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00396513

First Posted: November 7, 2006

Last Update Posted: November 7, 2006

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Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:

Serum testosterone

Secondary Outcome Measures:

regularity of menstrual cycle

serum lutropin

serum follitropin

serum lipids

serum DHEAS

serum SHBG

serum insulin

Study Start Date:

September 2005

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 40 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

PCO - ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396513